TiLock2 Pedicle Screw System GLC700

GUDID M719GLC7000

MIS Arc Distractor Variable Shaft

Genesys Orthopedics Systems LLC

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• Primary Device ID: M719GLC7000
• NIH Device Record Key: 633d48e4-fa46-4e7f-a470-7499ea865fe4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiLock2 Pedicle Screw System
• Version Model Number: 1
• Catalog Number: GLC700
• Company DUNS: 017921066
• Company Name: Genesys Orthopedics Systems LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GLC7000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171838

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

[M719GLC7000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-22
• Device Publish Date: 2024-04-12

On-Brand Devices [TiLock2 Pedicle Screw System]

• M719GLC48220: DMDSA Modular Screw Blade
• M719GLC48210: DMDSA Modular Screw Blade
• M719GLC4810: DMDSA Central Retractor Driver
• M719GLC4670: DMDSA Central Retractor
• M719GLC429S0: MIS Locking Star Setcap Starter - Short
• M719GLC125S0: K-Wire Tube - Short
• M719GLC4840: MIS Arc Distractor
• M719GL3270: 4-Sided Push Collar Ratchet Handle
• M719GL3220: 4-Sided Fixed Handle
• M719GLC7000: MIS Arc Distractor Variable Shaft